Utility of Remote Lung Auscultation in COPD With RESP™ Biosensor
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Statistically significant associations between RESP Biosensor-acquired lung findings and 1) subjective measure of respiratory symptoms measured by validated measurements tools and 2) home spirometry
研究概览
简要总结
Strados Labs has developed the Strados™ Respiratory Care Platform, including the RESP™ Biosensor System, which encompasses a clinically validated wearable, non-invasive, Bluetooth-enabled device capable of remotely collecting respiratory data. RESP was designed to extend both the geographical and temporal range of lung sound recordings, which can improve the remote monitoring of high-risk COPD patients. The RESP Biosensor continuously captures lung sounds and chest wall motions that are wirelessly transmitted through a mobile app to a web application to be analyzed for changes in respiratory health.
Preliminary data suggest good patient compliance and the potential for RESP to detect early COPD exacerbation. However, uncertainty on the optimal RESP monitoring procedure and insufficient longitudinal RESP data for definitive statistical correlation with COPD exacerbations warrant further study.
We plan to conduct an observational study to assess feasibility of home RESP remote patient monitoring and secondarily collect the longitudinal data necessary to establish the correlation between RESP based measures and standard of care measures of COPD symptom severity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Males and females between the ages of 40 and 80 with documented physician-diagnosed COPD and FEV1/FVC<0.70 or LLN based on post-bronchodilator spirometry
- •Hospitalized for COPD exacerbation with plan for discharge within 48 hours OR
- •Visiting pulmonologist post COPD-exacerbation within 14 days of discharge from hospital
- •Tobacco History: Current or Former Smoker
- •Has smoked at least 100 cigarettes in his/her lifetime
- •Patient can follow study procedures, including instructions for self-placement and operation of biosensor
- •Patient has experience/owns a smartphone
- •Patient is accessible by telehealth/telephone for duration of the study
- •Patient is able and willing to return to study site for study visits as necessary
排除标准
- •Patient is unable or unwilling to provide informed consent
- •Any condition that, in the opinion of the investigator, would limit the patient's activity in the study and/or adequate lung sound capture using the RESP™ wearable device
- •Patient with end-stage medical condition with expected survival no more than 6 months
- •History of adverse reaction or allergy to adhesives such as TegaDerm®
结局指标
主要结局
Statistically significant associations between RESP Biosensor-acquired lung findings and 1) subjective measure of respiratory symptoms measured by validated measurements tools and 2) home spirometry
时间窗: Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.
次要结局
- Univariate and multivariate assessment of predictors of up to 6-month total respiratory exacerbation rate (moderate + severe)(Recordings started prior to bedtime and continue for at least 6 hours, every other sleep for 6 months.)